[Federal Register Volume 82, Number 163 (Thursday, August 24, 2017)]
[Notices]
[Pages 40159-40160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17919]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-1956]


Identifying Trading Partners Under the Drug Supply Chain Security 
Act; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled 
``Identifying Trading Partners Under the Drug Supply Chain Security 
Act'' (draft trading partner guidance). FDA is issuing this guidance to 
assist industry and State and local governments in understanding how to 
categorize the entities in the drug supply chain in accordance with the 
Drug Supply Chain Security Act (DSCSA). This guidance explains how to 
determine when certain statutory requirements will apply to entities 
that may be considered trading partners in the drug supply chain. FDA 
is also soliciting public input specific to the activities of 
``private-label distributors'' of drug products and whether those 
activities fall within the definitions under DSCSA of the various 
trading partners.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 23, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and

[[Page 40160]]

Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-D-1956 for ``Identifying Trading Partners Under the Drug 
Supply Chain Security Act; Draft Guidance for Industry; Availability.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Melissa Mannion, Office of Compliance, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Identifying Trading Partners Under the Drug Supply Chain 
Security Act.'' The DSCSA (Title II of Pub. L. 113-54) establishes new 
requirements to develop and enhance drug distribution security by 2023. 
It does this, in part, by defining different types of entities in the 
drug supply chain as trading partners (i.e., manufacturers, 
repackagers, wholesale distributors, third-party logistics providers, 
and dispensers). Among other things, the DSCSA requires that trading 
partners of manufacturers, wholesale distributors, dispensers, and 
repackagers must meet the applicable requirements for being 
``authorized trading partners.'' In addition, the DSCSA outlines 
requirements for specific trading partners, including drug product 
tracing and licensure requirements. FDA has received questions about 
which types of entities are included in each of the trading partner 
definitions and this guidance is intended to help clarify and explain 
the relevant statutory provisions. The guidance covers who is 
considered to be a manufacturer, a repackager, a wholesale drug 
distributor, a third-party logistics provider, and a dispenser for 
purposes of certain DSCSA requirements.

II. Additional Issues for Consideration: Specific Request for Comments 
and Information

    In addition to comments on the draft guidance generally, FDA is 
requesting comments specifically related to the activities of private-
label distributors (PLDs), and whether those activities fall within the 
definitions under DSCSA of the various trading partners. FDA considers 
a PLD to be an entity that owns and distributes a manufactured product 
under its own label or trade name. Because there are many different 
business models for PLDs, resulting in situations where a PLD could be 
considered a manufacturer, wholesale distributor, or dispenser, we are 
asking for comments on how the different business models might impact a 
PLD's status as an authorized trading partner under the DSCSA.
    This draft guidance is being issued consistent with FDA's good 
guidance practices (see 21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Identifying 
Trading Partners under the Drug Supply Chain Security Act.'' It does 
not establish any rights for any person and is not binding on FDA or 
the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: August 18, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17919 Filed 8-21-17; 11:15 am]
 BILLING CODE 4164-01-P